Determining the Effect of Actimmune (Interferon Gamma 1b)Dose Titration on Flu-Like Symptoms in Healthy Volunteers (FLS)

Vidara Therapeutics

Status and phase: Unknown; Phase 1

Conditions: Adverse Effects in the Therapeutic Use of Interferon

Treatments: Drug: interferon gamma 1b

Study type: Interventional

Funder types: Industry

Identifiers

NCT01929382

VTRL Clin 2013-001

Details and patient eligibility

About

The most frequent side effects associated with Actimmune (interferon gamma 1b) therapy are the occurrence of 'flu-like symptoms' (FLS),which might include fever, chills, muscle aches, and tiredness. Earlier studies have demonstrated that these symptoms are common in healthy volunteers as well as in patients.

This study is designed to determine whether a titration of dosing reduces the frequency and severity of the FLS. A reported study with another interferon (interferon beta), demonstrated a reduction in the frequency and severity of the FLS when a titration of dosing was used. This study will compare the effects of the standard dose regimen with a titration regimen in healthy volunteers.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy volunteers
• Ability to understand purpose & risks
• BMI 18-32kg/m2
• Females on contraception

Exclusion criteria

• History of HIV,or pos test for HCV Ab,or HBsAg
• History of chronic fatigue syndrome or fibromyalgia
• Flu like illness within 1 month of start
• History of depression or other mood disorder
• History of malignant or pre-malignant disease
• History of severe allergic reactions
• Known allergy to Actimmune or its components
• History of major diseases
• Clinically Significant abnormal labs
• Pregnant or breastfeeding
• Clinically abnormal ECG
• History of alcohol or substance abuse
• Other study participation in last 4 weeks
• Serious infection within 3 months
• Use of Rx products within 4 weeks except contraceptives or dermatology products
• Vaccinations within 2 weeks
• Tobacco products ( with limitations)
• Cant/wont comply with study requirements
• Allergy shots within 1 month
• Blood donation with limitations
• Investigator discretion as to unsuitability

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups

Actimmune (interferon gamma 1b)

Active Comparator group

Description:

Subjects \> 0.5m2 BSA will receive 50 mcg/m2 BSA and subjects ≤ 0.5m2 BSA will receive 1.5mcg/kg/dose, as SC injections three times weekly, from week 1 to week 3.

Treatment:

Drug: interferon gamma 1b

Actimmune(interferon gamma 1b) titration

Experimental group

Description:

30% of the recommended dose as SC injections three times weekly in week 1, 60% the recommended dose as SC injections three times weekly in week 2, and at the recommended dose as SC injections three times weekly in week 3

Treatment:

Drug: interferon gamma 1b